The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Ivd (in Vivo Dosimeter), Model 1131.
| Device ID | K010449 |
| 510k Number | K010449 |
| Device Name: | IVD (IN VIVO DOSIMETER), MODEL 1131 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | Noel M Downey |
| Correspondent | Noel M Downey SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-15 |
| Decision Date | 2001-05-04 |